Zimmer Biomet Issues Correction Notice for Instinct Java System Cleaning Instructions
Zimmer Biomet is issuing a correction notice to provide updated cleaning and disinfecting instructions for the Instinct Java System and Universal Clamp System.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a voluntary precautionary recall involving updated documentation and instructions (cleaning/disinfecting) rather than a physical defect or reported injury, fitting the criteria for a moderate severity score.
Plain-English summary
Zimmer Biomet is initiating a Medical Device Correction Notice for the Instinct Java System (IFU reference: 046WAN0000T) and the Universal Clamp System (IFU reference: SNA027-N-90001). The purpose of this notice is to provide updated cleaning and disinfecting instructions for the use of these devices.
The Instinct Java System is a medical device used to stabilize one or more vertebral segments from the thoracic spine to the sacrum during the development of bone tissue. The recall affects 2,506 units distributed nationwide in the United States, including specific states such as Alabama, Arizona, Arkansas, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nevada, New Hampshire, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Washington, and Wisconsin.
This action is a correction notice rather than a standard recall for defective hardware or contamination. Users of these devices should refer to the updated instructions provided by Zimmer Biomet for proper cleaning and disinfecting procedures.
The recalled product
- Product
- Instinct¿ Java¿ System (IFU reference: 046WAN0000T) . Stabilizes one or more vertebral segments from the thoracic spine to the sacrum during the development of bone tissue.
- Manufacturer
- Zimmer Spine, Inc.
- Category
- Medical Device — Spinal Implant
- Hazard
- Affected units
- 2,506
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots
Distribution
Part of a larger recall action
This product is one of 2 recalled by Zimmer Spine, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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